Recall Z-0719-2024 ยท JAK System, X-Ray, Tomography, Computed
Philips North America
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
| Date | Jan 12, 2024 (initiated Dec 7, 2023) |
| Status | Open, Classified |
| Reason | If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG signal may lead to the decision to rescan the patient or delay in diagnosis during a clinical emergency. |
| Root cause | Component design/selection |
| Action | On December 7, 2023, the firm notified affected customers through URGENT Medical Device Correction Notice letters. Customers were informed that they may continue to use their Philips Incisive CT system in accordance with the intended use. However, to minimize the potential for loss of the ECG signal, customers should avoid frequently plugging and unplugging the PIM cable. In case of a connection failure, contact your local service representative and reference FCO72800782. Philips will contact you to schedule time for a Field Service Engineer to visit your site to replace the PIM cable with a |
| Quantity | 55 US; 1029 ROW |
| Distribution | Domestic distribution to the following states: AL CA CO FL GA HI IL IN KS KY LA MD MI MO MS ND NE NJ NY OH OK PA RI SC TX UT VT WA International distribution worldwide. |
| FDA record | Open on fda.gov |